Steroid for chronic subdural hematoma? A prospective phase IIB pilot randomized controlled trial on the use of dexamethasone with surgical drainage for the reduction of recurrence with reoperation

Abstract

Background: Chronic subdural hematoma is a common neurosurgical condition especially in the aging population. Burr hole for drainage is an effective treatment, yet recurrence is reported at 8 to 22 % worldwide, and 1-year mortality rates could be as high as 32 %. Our previous study on the use of dexamethasone as a primary nonsurgical treatment showed good response in selected group of patients. This study aims to assess the efficacy of dexamethasone with surgical drainage in the reduction of recurrence requiring reoperation. Methods: From October 2000 to September 2006, patients with chronic subdural hematoma admitted to the Prince of Wales Hospital, The Chinese University of Hong Kong, were randomized to surgical drainage with steroid versus surgical drainage only. The primary endpoint was symptomatic recurrence requiring reoperation. Results: Two hundred forty-eight patients were recruited and consented for the randomization during the study period. One hundred twenty-two received both surgery and steroid (the intervention arm) while 126 received surgery only (the control arm). The recurrence rate requiring reoperation was 6.6 % (8/122) and 13.5 % (17/126), respectively (p = 0.109). There was no significant difference in complications such as chest infection (p = 0.201) or wound infection (p = 0.987). Favorable outcome (Glasgow Outcome Score 4-5) was 104/122 (85.2 %) in the intervention group versus 105/126 (83.3 %) in the control group, respectively (p = 0.811). Based on the recurrence rate in our study, we generate a potential sample size of at least 594 patients (type I error = 5 %, power = 80 %, two-sided test) to detect a significant difference. Conclusions, brief summary, and potential implications: In this prospective pilot phase IIB randomized controlled study, steroid with surgical drainage had a lower recurrence with reoperation though statistically insignificant. It was safe with no significant difference in complication rates. This pilot study generates a potential sample size for a definitive larger double-blinded randomized controlled trial in the future.